The Agency for Health Care Administration wishes to acknowledge the
contributions of Alvin E. Smith, MD., chairman of the Florida Pain Commission and past
president of the Florida Medical Association, in the development of this guideline.

The Agency for Health Care Administration, in consultation with the
Florida Pain Commission, the Florida Board of Medicine and the Florida Board of
Osteopathic Medicine, endorses the following practice parameter or guideline pursuant to
the Florida Health Care and Insurance Reform Act of 1993, Chapter 93-129, Laws of Florida;
Florida Statutes s. 408.02Practice Parameters--of the Health Care Administration
Act; and Florida Statutes s. 458.326--Intractable Pain; Authorized Treatment--of the
Medical Practice Act. This practice parameter has been approved as a working document by
the Florida Board of Medicine and the Florida Board of Osteopathic Medicine.

This guideline is published for information, education and review by the
medical community, other professionals and the public. This practice guideline has been
created in recognition that some dangerous drugs, including controlled substances under
schedules II-V as provided in Florida Statutes s. 893.03, can be vital in the treatment of
pain, including intractable pain. They are useful for relieving and controlling many other
pain related symptoms.

These drugs may be prescribed for the treatment of pain and related
symptoms as a result of a prudent medical diagnosis, in proper doses and for appropriate
lengths of time, which in some cases, may be for as long as the pain or related symptoms
exist.

Pain, and many of the symptoms associated with intractable pain, can
result in subjective complaints and the appropriateness and the adequacy of drug and drug
doses will vary from patient to patient. The physician is expected to exercise sound
medical judgment in treating pain and its related symptoms with dangerous drugs and
controlled substances.

This generic guideline applies primarily (sic) to the treatment of
chronic and intractable pain with the use of dangerous drugs and controlled substances. At
the end of the text, there are additional Agency for Health Care Administration endorsed
guidelines that target pain management. These guidelines contain information about the
management of specific acute and chronic pain and injury conditions using prescription
drugs, controlled substances and other modalities. The guidelines also contain the
mandated scientific base for this generic pain management guideline.

Guidelines are not intended to be used as fixed protocols. They are
parameters for patient management strategies which are not entirely inclusive or exclusive
of all methods of reasonable care that can achieve comparable results. They do permit the
consideration of the unique exigencies of each individual and available resources. Many
patients will require more or less treatment to achieve relief from pain.

Treatment must be based on patient need as well as professional
judgment. Therefore, these guidelines can be tailored to fit distinctive patient needs
that are affected by the medical setting, the available resources and by other factors.
Deviations can be justified by individual circumstances.

While standards are intended to be rigid and mandatory, making
exceptions rare and troublesome to justify, guidelines are more flexible, but it is
advisable they be followed as closely as is prudent. Guidelines are revisited every three
years or less and reviews are based on scientific updates.

FLORIDA GENERIC CLINICAL PRACTICE GUIDELINE

MANAGEMENT OF PAIN USING DANGEROUS DRUGS AND CONTROLLED SUBSTANCES

PART I

PREFACE

The State of Florida recognizes that pain, including intractable pain,
is often undertreated. Unrelieved pain can have harsh and sometimes disastrous influence
on the quality of life for patients and their families.

PAIN MANAGEMENT SHOULD BE A HIGH PRIORITY IN FLORIDA

Principles of quality medical practice dictate that citizens of Florida
who suffer from pain should seek relief-with treatment that is currently available. The
appropriate application of current knowledge and treatments can greatly improve the
quality of life for many Florida citizens and reduce the morbidity and costs associated
with untreated pain.

In addition to promoting competent patient care, these guidelines are
intended to help physicians avoid investigation if controlled substances are appropriately
prescribed for short or long-term pain management.

PRESCRIBING DANGEROUS DRUGS AND CONTROLLED SUBSTANCES FOR PAIN

The proper treatment for any patient's pain depends upon a careful
diagnosis of the etiology of the pain, selection of appropriate and cost effective
treatments and the ongoing evaluations of the results of treatment. Patients with chronic
pain may demand more time of the practitioner because of the complexity of their problem.

Opioid analgesics and other dangerous and controlled substances are
useful for pain treatment. They are the cornerstone of treatment for acute pain due to
trauma or surgery and of chronic pain due to progressive diseases, such as cancer. Other
than that specified in the Physician's Desk Reference (PDR), large doses, if documented,
may be necessary to control severe pain. Extended therapy may also be needed to alleviate
chronic pain. Published formularies, relating to commercial financial incentives, should
not be a deterrent to achieving optimal pain relief.

Opioid analgesics may also be useful in treating patients with
intractable nonmalignant pain especially when efforts to remove or treat the pain with
other modalities have failed. Such intractable pain may have a number of different
etiologies and might require several treatment methods. In addition, the extent to which
pain is associated with physical and psychosocial impairment varies greatly. Therefore,
when patients are selected for therapy trials using dangerous drugs and opioid therapy,
care should be used to assess the pain as well as the patient's disability. The duration
of drug therapy should depend on the physician's evaluation of the results of treatment,
including the degree of pain relief, the changes in physical and psychological functioning
and the appropriate utilization of health care resources.

Addiction in relation to these substances should be placed in proper
perspective. Physical dependence and tolerance are normal physiological consequences of
extended opioid therapy and are not the same as addiction. Addiction is a behavioral
syndrome characterized by psychological dependence and aberrant, drug-related behaviors.
Addicts use drugs in a compulsive manner and not for medical purposes. An addict may also
be physically dependent or tolerant. Patients with chronic pain should not be considered
addicts merely because they are being treated with opioids. Physicians need to be
cognizant of the fact that patients with a history of drug abuse may be particularly
problematic to the management of pain.

PAIN MANAGEMENT, CONTROLLED SUBSTANCES AND THE LAW

Federal government laws and regulations and those of the State of
Florida impose special requirements for dangerous drugs and controlled substances
prescription. These regulations are aimed at preventing harm to the consumer from
dangerous prescription drugs which are diverted to non medical uses. It is legitimate
medical practice for physicians to prescribe controlled substances for the treatment of
pain, including intractable pain. The Agency for Health Administration supports the
examination of prescriptions for analgesics and opioids for the treatment of pain. This
examination must be based on the documented diagnosis and treatment rather than on the
drug dosage or on the number of prescriptions written.

Concerns about regulatory scrutiny should not cause physicians to be
reluctant to prescribe or administer dangerous and controlled substances, including
Schedules II-V drugs as provided for in Florida Statutes s. 893.03, for patients with
legitimate medical needs. Physicians need not fear administrative action when prescribing
dangerous drugs and controlled substances to patients in their care for a pathology or
condition when the prescription is issued after a good faith examination and there is
medical indication for the prescription.

The regulatory boards may identify a pattern of dangerous and controlled
substance use which merits further examination, but private, courteous and professional
inquiry can usually determine whether the physician is appropriately prescribing for
patients in good faith or whether an investigation is warranted. The Florida Board of
Medicine and the Florida Board of Osteopathic Medicine must judge the prescription
validity relative to the physician's documented diagnosis and treatment and if the
prescribed drugs are appropriate for the patient's condition. Predetermined limits should
not be placed on dosages or length of drug therapy.

It is the goal of the Agency for Health Care Administration to change
practitioner perception of regulatory scrutiny and recognize the commitment of regulatory
boards to improving pain management in order to enhance the quality of lives of
pain-affected patients in Florida. Federal and State laws and regulatory policies should
not hamper the appropriate use of dangerous drugs and controlled substances for the relief
of pain.

PART II

PRACTICE AND REGULATORY GUIDELINES

The Florida Board of Medicine and the Florida Board of Osteopathic
Medicine may use the following guidelines to determine whether conduct violates the
physician's respective practice act, including Florida Statutes s. 458.326--Intractable
Pain; Authorized Treatment--of the Florida Medical Practice Act, below, in regard to
prescribing, administering, ordering or the dispensing of pain medications and other drugs
and to address their side effects.

Excerpted from Florida Statutes Chapter 458, Medical Practice

Florida Statutes s. 458.326 - Intractable pain; authorized treatment.

(1) For the purposes of this section, the term "intractable
pain" means pain for which, in the generally accepted course of medical practice, the
cause cannot be removed and otherwise treated.

(2) Intractable pain must be diagnosed by a physician licensed under
this chapter and qualified by experience to render such diagnosis.

(3) Notwithstanding any other provision of law, a physician may
prescribe or administer any controlled substance under Schedules II-V, as provided for in

(4) 893.03, to a person for the treatment of intractable pain, provided
the physician does so in accordance with that level of care, skill, and treatment
recognized by a reasonably prudent physician under similar conditions and circumstances.

(5) Nothing in this section shall be construed to condone, authorize, or
approve mercy killing or euthanasia, and no treatment authorized by this section may be
used for such purpose. History.--s. 3, ch. 94-96.

DEFINITIONS

INTRACTABLE PAIN - A pain state in which the cause of the pain cannot be
removed or otherwise treated and which, in the generally accepted course of medical
practice, no relief or cure of the cause of the pain is possible or none has been found
after reasonable efforts.

NONTHERAPEUTIC USE - A medical use or purpose that is not legitimate in
nature or in manner.

ABUSER OF NARCOTIC DRUGS, CONTROLLED SUBSTANCES AND DANGEROUS DRUGS - An
individual who takes a drug or drugs for other than legitimate rnedical purposes.

1. The treatment of pain, including intractable pain, with dangerous
drugs and controlled substances has a legitimate medical purpose when performed in the
usual course of medical practice.

2. Physicians duly authorized to practice under their respective
practice act and to prescribe controlled substances and dangerous drugs in Florida, shall
not be subject to disciplinary action by their respective licensure board for prescribing,
ordering, administering or dispensing dangerous drugs or controlled substances for the
treatment and relief of pain, including intractable pain, in the usual course of
professional practice for a legitimate medical purpose in compliance with applicable state
and federal law.

3. The prescribing, ordering, administering or dispensing of dangerous
drugs or controlled substances for pain will be considered to be for a legitimate medical
purpose if based upon scientific knowledge of the treatment of pain, including intractable
pain; and are not in contravention of applicable state and federal law, and if prescribed,
ordered, administered or dispensed in compliance with the following guidelines where
asoronnate and as is necessary to meet the individual needs of the patient.

A physician will be considered in compliance if:

a. The medication is prescribed after a documented patient history and
physical examination by the physician prescribing or providing the medication, which
includes: an assessment and consideration of the physical and psychological impact of the
pain, any patient history or potential for substance abuse, for coexisting diseases and
conditions and the prescience of a recognized medical indication for the use of a
dangerous drug or controlled substance.

b. If medications are prescribed pursuant to a written treatment plan
tailored for the individual needs of the patient and if treatment progress and success can
be evaluated with stated objectives such as pain relief and improved physical and
psychosocial function. Such a written treatment plan will consider pertinent medical
history and physical examination as well as the need for further testing, consultations,
referrals or the use of other treatment modalities.

c. The physician should discuss with the patient, significant other(s)
or legal guardian, if appropriate, the risks, i.e., narcotic bowel syndrome (inforrnation
attached), addiction and other side effects in comparison to the benefits from the use of
dangerous and controlled substances.

d. The patient will be subject to documented periodic review of the care
by the physician at reasonable intervals and in view of the individual circumstances of
the patient in regard to progress toward reaching the stated objectives. The review will
take into consideration the course of medications prescribed, ordered, administered or
dispensed, as well as any new information about the etiology of the pain.

e. Complete and accurate records of the care provided are kept as set
forth in a-d, above. When controlled substances are prescribed, records are made which
include names, quantities prescribed, dosages and number of authorized refills. This
record takes into account that pain-affected patients with a history of substance abuse,
or patients who live in an environment that

may pose a risk for medication misuse or diversion, may require special
consideration. Management of these patients may warrant closer monitoring by the physician
managing the pain and require consultation with appropriate health care professionals.

4. A physician's decision not to adhere strictly to the provisions of
number 3, above, will not if "good faith or cause" is shown, constitute grounds
for board disciplinary action. Each case of prescribing for pain will be evaluated on an
individual basis. The physician's conduct will be evaluated to a great extent by the
treatment outcome, taking into account: 1/ whether the drug used is medically or
pharmacologically recognized to be appropriate for the diagnosis, 2/ the patient's
individual needs, including any improvement in functioning, and 3/ recognizing that some
types of pain cannot be completely relieved.

5. If the provisions set out in numbers 1-4, above, are met, and if all
drug treatment is properly documented, the board will consider such practices as
prescribing in a therapeutic manner, and as prescribing and practicing in a manner
consistent with public health and welfare.

6. Quantity of pharmaceutical and chronicity of the prescription will be
evaluated on the basis of the documented appropriate diagnosis and treatment of the
recognized medical indication. Documented persistence of the recognized medical
indication, and properly documented follow-up evaluations with appropriate continuing care
as set out in these guidelines, will also be evaluated.

7. A physician may use any number of treatment modalities for the
treatment of pain, including intractable pain, which are consistent with legitimate
medical purposes.

PART III

OTHER ENDORSED PAIN MANAGEMENT GUIDELINES

The Agency for Health Care Administration has endorsed the following
pain management guidelines. These guidelines provide the scientific base for the generic
guideline. The following listings were excerpted from the Catalog of Endorsed Practice
Parameters and Their Sources, 1993-1995.

PRACTICE PARAMETER SUBJECT: MEDICAL PAIN MANAGEMENT

Endorsed on October 14, 1994, under the authority of s.408.02, Florida

Statutes

NO. GUIDE GUIDELINE ORDER FROM COST

7

1 1.1 Clinical Practice Guideline - Agency for Health Care

Free copy

ACUTE PAIN MANAGEMENT: Administration from

OPERATIVE OR MEDICAL (AHCA) AHCA

PROCEDURES AND TRAUMA. Medical Guidelines while

145 pages. U.S. Department of Clearinghouse supplies

Health and Human Service, Public 2727 E. Mahan

Drive, last

Health Service, Agency for Health Bldg. 3

Care Policy and Research Tallahassee, FL 32308-

(AHCPR). 1992. AHCPR 5403

Publication No. 92-0032. FAX (preferred:

(904) 488-1261

Telephone:

(904) 922-5505

2 1.2 Quick Reference Guide for or write:

Freecopy

Clinicians -ACUTE PAIN AHCPR from

MANAGEMENT IN ADULTS: Center for Research AHCA

OPERATIVE PROCEDURES. Dissemination and while

22 pages (same publisher Liaison supplies

as above). 1992. AHCPR P.O. Box 8547 last

Publication No. 92-0019. Silver Springs, MD

20907

or call:

AHCPR clearinghouse

1 -800-358-9295

PRACTICE PARAMETER SUBJECT: MEDICAL PAIN MANAGEMENT

Endorsed on October 14, 1994, under the authority of s. 408.02, Florida